Night Time Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid, 355 mL — NDC 49580-0343-2 (Billing 49580-0343-02)
This is a package of 355 mL of Night Time Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid from P & L Development, LLC, marketed since Oct 2014 and currently FDA-listed, this package's marketing is listed to end Dec 2026. It is the main listing for this product, which comes in 4 package sizes.
NDC database record
One package, one record: these facts belong to NDC 49580-0343-2 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 49580 labeler · 0343 product · 2 package
- Package marketed since
- Oct 31, 2014
- Package marketing ended
- Dec 31, 2026
- Sample package
- No — commercial package
- Barcode (UPC)
- 0349580343061
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1043400
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗This is an over-the-counter liquid product taken by mouth, marketed under FDA's OTC monograph rules for nighttime cold and flu relief. It contains acetaminophen, commonly used to reduce fever and relieve pain; dextromethorphan, typically used to suppress cough; and doxylamine succinate, an antihistamine generally used to reduce runny nose and sneezing while also promoting drowsiness. The product is intended for oral use in adults and children according to the dosing information on the package label.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 49580-0343-02 You're viewing this Main listing | 355 mL in 1 BOTTLE, PLASTIC | 2014-10-31 | Dec 31, 2026 | Active |
| 49580-0343-04 49580-0343-4 | 118 mL in 1 BOTTLE, PLASTIC | 2014-10-31 | Dec 31, 2026 | Active |
| 49580-0343-06 49580-0343-6 | 177 mL in 1 BOTTLE, PLASTIC | 2014-10-31 | Dec 31, 2026 | Active |
| 49580-0343-08 49580-0343-8 | 237 mL in 1 BOTTLE, PLASTIC | 2014-10-31 | Dec 31, 2026 | Active |
You're viewing the largest of 4 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 49580-0343-04?
What NDC number is used to bill for this package of Night Time Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid?
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 23OV73Q5G9
Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII XY6UN3QB6S
A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from P & L Development, LLC labeler code 49580
- Isopropyl alcohol 91 percent ReadyInCase 91 mL/100mL Liquid NDC 49580-0277-3
- Pain and Fever Childrens Acetaminophen 160 mg/5mL Suspension NDC 49580-0282-2
- Childrens Allergy Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid NDC 49580-0292-2
- Childrens Dye Free Allergy Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid NDC 49580-0293-4
- Sleep Aid NightTime Diphenhydramine HCl 50 mg/30mL Liquid NDC 49580-0314-2
- Mineral oil 100 mg/100mL Oil NDC 49580-0334-6
- Nighttime Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid NDC 49580-0346-2
- Sore Throat ReadyInCase Phenol 1.4 g/100mL Spray NDC 49580-0376-6
- Childrens Triacting Nighttime Cold and Cough ReadyInCase Diphenhydramine HCl, Phenylephrine HCl 2.5 mg/5mL; 6.25 mg/5mL Liquid NDC 49580-0379-4
- Tussin Long Acting Cough READYINCASE Dextromethorphan HBr 30 mg/10mL Liquid NDC 49580-0383-4
- Tussin DM Cough and Chest Congestion Adult Dextromethorphan HBr, Guaifenesin 20 mg/10mL; 200 mg/10mL Liquid NDC 49580-0385-2
- Witch Hazel ReadyInCase 86 g/100mL Liquid NDC 49580-0390-6
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache fever sore throat runny nose and sneezing cough due to minor throat and bronchial irritation
⏱️ Dosage and Administration ▾
Directions do not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use When using other Day Time or Night Time products, carefully read each label to insure correct dosing
⚠️ Warnings ▾
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert : Acetaminophen may cause severe skin reactions.Symptoms may include: skin reddening blisters rash. If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information each 30 mL contains: potassium 10 mg each 30 mL contains : sodium 38 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
🧪 Active Ingredient ▾
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients acesulfame potassium, alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
🎯 Purpose ▾
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine
📄 Do Not Use ▾
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin
📄 When Using This Product ▾
When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📄 Questions or Comments ▾
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Compare to the active ingredients in Vicks® NyQuil® Cold & Flu* Night Time Cold & Flu Acetaminophen dextromethorphan HBr doxylamine succinate Relieves: aches, fever & sore throat cough runny nose & sneezing for ages 12 & over alcohol 10% cherry flavor FL OZ (mL) *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by: PL Developments 11865 S. Alameda St Lynwood, CA 90262
Product Label READYinCASE NightTime Cold & Flu Cherry Flavor Acetaminophen 650 mg, Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |